This makes the new indication for Dupixent very important for Sanofi as it searches for a blockbuster to transform its fortunes. The FDA is set to make a decision on Dupixent’s new indication on ...

Sanofi and Regeneron's Dupixent already boasts a long list of FDA-approved indications, and the latest to be reviewed could throw a lifeline to patients with a rare and debilitating autoimmune ...

Five times more adults on Dupixent achieved sustained disease remission at 36 weeks compared to placebo; significant reductions were also seen in disease severity and itch Dupixent also ...

The sBLA is supported by data from a pivotal trial evaluating the efficacy and safety of Dupixent in 106 adults with moderate-to-severe BP. The primary endpoint was met, with five times more ...

If approved, Dupixent would be the first and only targeted medicine to treat bullous pemphigoid in the U.S. The submission was supported by a pivotal study which met its primary endpoint.

(RTTNews) - Regeneron Pharmaceuticals Inc. (REGN) and Sanofi presented positive results from the pivotal ADEPT Phase 2/3 trial evaluating the investigational use of Dupixent (dupilumab) in adults ...

If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S.; FDA decision expected by June 20, 2025 Priority Review granted based on positive pivotal results ...